Allogeneic Skin Grafting

NCT04015947 | Withdrawn DMC FDA Device

• 1 other identifier: DERM-2016-25255
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The primary study objective is to evaluate local response to split-thickness skin grafts from a matched bone marrow donor to chronic GVHD-affected skin in a hematopoietic stem cell transplant patient.

Conditions

GVHD

Outcome Measures

Primary Outcomes (2)

• Change in CGAA

  Evaluation of clinical improvement in inflammation and sclerosis based on visual inspection and photodocumentation with outcome outcomes determined using the Chronic GVHD Activity Assessment (CGAA) to measure therapeutic response. The CGAA is an 8-item assessment measuring symptom severity of GVHD on a scale from 0 (not present) to 10 (as bad as you can imagine). Global score is calculated by summing items.

  Change from baseline up to 12 months

• Change in ELISA Markers of GVHD

  Chronic GVHD lesions will be assessed following transplantation through serum ELISA assays of elafin and CXCL10 (validated biomarkers for assessment of GVHD disease activity)

  Change from baseline up to 12 months

Study Arms (1)

Active treatment

EXPERIMENTAL

This is an open label, single-institution pilot study to evaluate local response to split-thickness skin grafts from a matched bone marrow donor to chronic GVHD-affected skin in a hematopoietic stem cell transplant patient.

Device: CelluTome® Epidermal Harvesting System

Interventions

CelluTome® Epidermal Harvesting System DEVICE

split-thickness skin grafts from a matched bone marrow donor using the CelluTome® Epidermal Harvesting System

Also known as: split-thickness skin grafts

Active treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects will be eligible to participate in the study if all of the following conditions exist:
• Diagnosis of chronic, sclerotic, cutaneous graft versus host disease with one or more areas of cutaneous sclerosis and
• More than 1 year after HCT with stable hematopoietic engraftment and original transplant donor is available and agrees to be the epidermal donor for this study
• Stable (mixed or full) donor hematopoietic engraftment
• Original transplant donor is available and willing to be the epidermis donor
• Site for skin grafting free of cellulitis or other evidence of infection
• Insurance pre-authorization for procedure
• Voluntary written consent prior to any research related procedures or treatment.
• Age \> 18 years (based on prior safety testing of the device)
• Healthy on physical examination in the opinion of the evaluating physician
• Known negativity for Hepatitis B and C, HIV, and HTLV1/2
• Voluntary written consent prior to any research related procedures

You may not qualify if:

• Subjects will be excluded from participation in the study if any of the following conditions exist:
• Patient with cutaneous infection
• Patient with recent change in medical management of chronic cutaneous GVHD (new medication or therapy, or change in dosing of existing medication) within one month of start date.

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55414, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is an open label, single-institution pilot study to evaluate local response to split-thickness skin grafts from a matched bone marrow donor to chronic GVHD-affected skin in a hematopoietic stem cell transplant patient.

Study Record Dates

• First Submitted: August 7, 2018
• First Posted: July 11, 2019
• Study Start: August 1, 2019
• Primary Completion: April 1, 2021
• Study Completion: April 1, 2021
• Last Updated: April 20, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)